Therapeutic Areas

Sixteen disease areas. One senior team.

Consultants who know your science, your endpoints, and your division of the agency — not just the regulations around them. We staff by the biology of your program, not a generalist rotation.

  • 16Disease areas
  • 4FDA centers & offices
  • End⁠-⁠to⁠-⁠endIND to approval
Physician reading a wall of brain MRI and CT scans

Depth, not coverage

Regulations are the same for everyone. The review isn’t.

A reviewer in oncology weighs a surrogate endpoint differently than one in cardiology. A rare-disease division reads a 40-patient dataset differently than an anti-infectives team reads 4,000. The rulebook is public; the way each division applies it is learned.

Our consultants have sat on the other side of those meetings — in the therapeutic area you’re working in, at the center that will review you. So the strategy we bring already anticipates the questions your program will actually get asked.

The Directory

Find your indication

Sixteen areas of deep expertise. Each links to how we think about its science, its endpoints, and its regulatory path.

  • CT scanner in a bright modern imaging suite
    OncologySolid tumor and heme-onc, IND through accelerated approval.
  • Glowing rendering of an immune cell under attack
    Immunology & InflammationBiologics and small molecules across autoimmune disease.
  • Scientist carrying a rack of samples through a genetics laboratory
    Rare Disease & Orphan DrugsOrphan designations, small populations, big evidentiary questions.
  • Gloved hand loading a sample into stainless processing equipment
    Cell & Gene TherapyAdvanced therapies with no precedent to lean on.
  • Syringe resting across vaccine vials
    Infectious Disease & VaccinesVaccines and anti-infectives, first trial to licensure.
  • Blood units collected during a transfusion procedure
    HematologyFrom factor products to first-in-class heme therapies.
  • Cardiac monitor displaying vitals on a clinical cart
    CardiovascularOutcomes-scale programs and combination CV devices.
  • Research participant wearing an EEG headset
    Neuroscience & CNSNovel mechanisms and endpoints the agency will question.
  • Telemedicine consultation on a tablet propped at a bedside
    Digital HealthDigital therapeutics and connected care, cleared and kept compliant.
  • Glucose meter, lancet, and syringes arranged on a lilac surface
    Endocrinology & MetabolicDiabetes and obesity, and the device-drug border they live on.
  • Surgical robotic arm poised in an operating suite
    Medical Devices & DiagnosticsClass I through PMA, bench to post-market.
  • Clinicians beside an anesthesia and ventilation workstation
    Respiratory & PulmonologyInhaled combinations and device-dependent delivery.
  • Colorful culture plates in a microbiology laboratory
    Microbiome & Novel ModalitiesLive biotherapeutics and modalities without a rulebook.
  • Patient showing a dermatologic condition at the collarbone
    DermatologyTopicals, biologics, and aesthetic-medical crossovers.
  • Patient examined at a slit lamp in an eye clinic
    OphthalmologyFront and back of the eye — drugs, devices, combinations.
  • Expecting mother reviewing results with her clinician
    Women’s HealthLong-underserved indications, finally getting programs.

Know your reviewer

Every indication has a home at the agency.

Your therapeutic area determines which FDA center or office reviews your submission — and each reads the evidence its own way. We place consultants who have worked inside the one that will read yours.

Linear accelerator radiotherapy machine in a treatment suite OCE

Oncology Center of Excellence

Coordinates oncology review across the drug, biologic, and device centers — the through-line for solid-tumor and hematologic malignancy programs.

  • Oncology
  • Hematology
Pharmaceutical tablets on a dark reflective surface CDER

Drugs — CDER

Small molecules and most therapeutic biologics. The review divisions here run the majority of chronic-disease and specialty programs.

  • Immunology
  • Cardiovascular
  • Neuroscience
  • Endocrine
  • Respiratory
  • Dermatology
Scientists in full protective gowning inside a biologics cleanroom CBER

Biologics — CBER

Vaccines, blood products, and the advanced therapies — cell, gene, and live biotherapeutics — where precedent is thin and the science moves fastest.

  • Vaccines
  • Cell & Gene
  • Microbiome
State-of-the-art operating room equipped with advanced surgical devices CDRH

Devices & Diagnostics — CDRH

Devices, in-vitro diagnostics, and software as a medical device — plus the device constituent of every combination product.

  • Medical Devices
  • Digital Health
  • Diagnostics

Working a combination product or companion diagnostic? Those cross center lines — and the hand-off is where programs stall. We staff for the intercenter path, not just the lead center.

Don’t see your indication? The team is deeper than the page.

Tell us the molecule, the modality, and the meeting on your calendar. We’ll match you to consultants who have been in that room.

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